Revalia Bio Awarded Up To $26.7 Million ARPA-H Contract Award to Advance Drug Development with Human Data Trials

Funding backs a human-first approach to drug safety and efficacy, reducing reliance on animal testing and accelerating therapies for patients.

NEW HAVEN, CT / ACCESS Newswire / December 5, 2025 / Revalia Bio (Revalia), developer of the Human Data Trial platform, today announced that they are serving as the technical lead for an up to $26.7M contract that they were awarded under the Advanced Research Projects Agency for Health (ARPA-H) Computational ADME-Tox and Physiology Analysis for Safer Therapeutics (CATALYST) program. The project, titled An Integrated Human Data Approach to Unlock the Future of In Silico Learning Models, supports Revalia's mission to redefine how drug safety and efficacy are predicted before clinical trials.

Revalia will lead the effort to build advanced AI-driven models trained on Human Data Trials, living systems derived from donated human organs, organ-on-chip platforms, and multimodal datasets. The goal is to reduce reliance on animal models and better predict how drugs behave in the human body, cutting costly late-stage failures and accelerating safer therapies.

"This award is a turning point for Revalia and for the broader field of human-based trials," said Greg Tietjen, PhD, CEO and Co-Founder of Revalia. "It's a validation for us that confirms that the era for human data is here. Donated human organs are the Rosetta Stone of human-centered development, and our Human Data Trials platform transforms that gift into actionable insight for safer, more effective drugs. Most importantly, this program allows us to further deliver on our mission to honor the legacy of every donor by turning the loss of one life into knowledge that shapes the future of medicine."

A Human-First Alternative to Animal Models

The ARPA-H CATALYST program is designed to accelerate safer, faster drug development by enabling more accurate predictions of safety and efficacy in investigational new drugs (INDs). CATALYST is led by ARPA-H Health Science Futures Mission Office Acting Deputy Director Andy Kilianski, Ph.D. Revalia's integrated approach aligns with recent NIH and FDA initiatives to reduce reliance on animal testing by providing rigorous, clinically grounded human datasets to support regulatory innovation.

"Drugs should be tested in the same biology, from the same patients, they are meant to treat," said Janet Nikolovski, PhD, Chief Data and Innovation Officer at Revalia. "We are generating a unique, integrated human dataset encompassing everything from high level patient data to organ specific physiology and comprehensive molecular level analyses. These data will train models that we believe will better simulate clinical outcomes and reduce the risk of drug failure in clinical trials. This has the potential to change the paradigm for drug development, bringing better and faster therapies to patients who need them."

Collaborative Ecosystem: The Human Data Stack

Revalia's Human Data Trials platform forms the foundation of the company's broader Human Data Stack, a framework that integrates donor organs, organoids, and organ-on-chip systems into a unified translational system. Revalia will collaborate with a national consortium that brings together:

• A leading engineering research institute developing high-dimensional datasets through advanced platforms.

• A regional nonprofit organization focused on expanding access to organ donation for scientific study.

• An academic research lab specializing in artificial intelligence and machine learning to unlock predictive insights.

• A top 10 pharma company looking to integrate New Approach Methodologies (NAMs) into their standard workflows to accelerate the pace of pre-clinical development

"This project unites clinicians, biologists, engineers, and AI/ML experts to build advanced in silico models of human physiology that predict drug metabolism, pharmacokinetics, and toxicity," said Nabil Boutagy, PhD, Director of Human Data Trial Operations at Revalia. "By integrating diverse expertise and generating multi-omic data at scale, we aim to cut drug development costs and timelines while guiding optimal dosing for patients."

ABOUT REVALIA BIO:

Revalia Bio is transforming how new medicines are developed by offering on-demand access to real, functional human data. Built on decades of research in human organ perfusion, Revalia's platform enables rigorous testing in donated human organs maintained under clinical conditions. This makes it possible to run Human Data Trials - studies that generate trial-quality data on safety, efficacy, and mechanism at any stage of development, before a molecule ever reaches a patient. For more information, visit www.revaliabio.com.

MEDIA CONTACT:

Nina Pfister, MAG PR at E: nina@mooringadvisorygroup.com; P: 781-929-5620

SOURCE: Revalia Bio